Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus
Phase 1/2
Completed
NCT02472795
| Condition | Systemic Lupus Erythematosus |
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| Phase | Phase 1/2 |
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| Sponsor | Viatris Innovation GmbH |
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| Status | Completed |
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| Enrollment | 105 participants |
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| Interventions | Matching placebo, Cenerimod |
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| Start date | Jun 1, 2015 |
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| Completion date | Jan 23, 2017 |
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| Results posted | Feb 26, 2020 |
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Summary
International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients.
Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT)
Baseline to end-of-treatment (EOT) (up to 12 weeks) · 10^9 cells/L
| Cenerimod 0.5 mg (Part A) | -0.26 ± 0.48 10^9 cells/L |
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| Cenerimod 1 mg (Part A) | -0.96 ± 0.68 10^9 cells/L |
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| Cenerimod 2 mg (Part A) | -0.86 ± 0.61 10^9 cells/L |
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| Cenerimod 4 mg (Part B) | -0.87 ± 1.24 10^9 cells/L |
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| Matching Placebo | -0.33 ± 0.72 10^9 cells/L |
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| p-value | 0.39 |
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| Mean Difference (Final Values) | -0.17 (95% CI -0.56–0.22) |
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Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment
Baseline, Week 2, Week 4, Week 8, Week 12, end-of-treatment Visit (up to 12 weeks) · 10^9 cells/L
| Cenerimod 0.5 mg (Part A) | 1.37 ± 0.52 10^9 cells/L |
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| Cenerimod 1 mg (Part A) | 1.71 ± 0.82 10^9 cells/L |
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| Cenerimod 2 mg (Part A) | 1.62 ± 0.75 10^9 cells/L |
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| Cenerimod 4 mg (Part B) | 1.88 ± 0.77 10^9 cells/L |
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| Matching Placebo | 1.65 ± 0.88 10^9 cells/L |
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| Cenerimod 0.5 mg (Part A) | -0.13 ± 0.56 10^9 cells/L |
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Open in BENITIONS
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